Starting from December 1, 2009, Hong Kong has now set up the process to list Class D In Vitro Diagnostic (IVD) Medical Devices under the Medical Device Administration Control System.
IVD medical devices are classified in Hong Kong similar to the guidelines outlined by the Global Harmonization Task Force, GHTF. There are four classes according to risk level (Class A to D) where Class A is the lowest risk and Class D the highest. Examples of Class D IVD medical devices include Hepatitis B and HIV tests.
To list a Class D IVD medical device, applicants will submit Application Form MD-IVD and the Essential Principles Conformity Checklist. Both forms are available on the Medical Device Control Office’s website athttp://www.mdco.gov.hk. Applicants will need to fill in information about the device, details on the Local Responsible Person in Hong Kong, marketing approvals overseas, quality management system information, etc.
The detailed guidelines are listed under GN-06: Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices and TR-006: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Listing of other classes of IVD medical devices will be launched at a later stage.